JP4789951B2 - Surgical safety knife - Google Patents

Description

CROSS REFERENCE TO RELATED APPLICATIONS AND CLAIM OF BENEFITS The present invention claims the benefit of US Provisional Patent Application No. 60 / 623,741, filed Oct. 29, 2004.

  The present invention relates generally to surgical scalpel instruments and, more particularly, to a surgical safety scalpel for medical use.

  The medical industry is the second fastest growing sector in the US economy, with over 12 million workers. Nearly 80% of this medical workforce is women. Health care workers face a wide range of risks on the job, including needlestick injury and sharp injury, back pain, latex allergies, violence and stress. While it is possible to prevent or reduce the exposure of health care workers to these hazards, in reality, the number of occupational accidents and illnesses experienced by health care workers is increasing. The occupational accident rate for health care workers has increased over the last decade. In contrast, the two most dangerous industries, agriculture and construction, are safer today than 10 years ago.

  While accurate national data is not available on the annual number of needlesticks and other percutaneous injuries in health care workers, estimates indicate that between 600,000 and 800,000 such injuries occur annually. ing. About half of these injuries will not be published. Data from EPINet (exposure prevention information network) suggests that in an average hospital, workers suffer approximately 30 needlestick injuries per 100 beds per year.

  While most reported needlesticks and sharp injuries have occurred in relation to nursing staff, laboratory staff, doctors, housekeepers and other health care workers are also victims. Some of these injuries expose workers to blood-borne pathogens that can cause infections. Among the more serious infections are hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV). Infections caused by each of these pathogens are potentially life threatening but can be prevented.

  The emotional impact of needlesticks and sharp injuries is harsh and persists for long periods of time even when not infected with a serious infection. This effect is particularly severe when the injury is related to exposure to HIV. In a survey of 20 health care workers exposed to HIV, 11 were reported to have suffered severe, severe distress, 7 experienced persistent moderate distress, and 6 resigned as a result of exposure. In addition, stress reactions that require consulting have been reported. Not knowing the source patient's infection status can exacerbate the stress of health care workers. In addition to exposed health workers, colleagues and family members may suffer mental damage.

  The best way to address health and safety issues is to set up a comprehensive prevention program that involves employees and managers that considers all aspects of the work environment. Implementing the use of improved engineering controls is an element of such a comprehensive program. However, other preventive strategy elements that must be addressed include other modifications of hazardous work practices, changes in administrative responses to environmental hazards from needles (eg, rapid removal of trash bins containing sharps) , Safety education and awareness, feedback on safety improvements and actions taken on permanent issues.

  In many cases, improved engineering control is one of the most effective approaches to reducing occupational accidents, and is therefore an important element of a needlestick prevention program. Such control includes the elimination of unnecessary needle use and the implementation of devices with safety features. Some sources have identified some desirable features related to safety devices, which do not use needles, incorporate safety functions as an integral part of the device, ie operate passively (ie, It does not need to be activated by the user), can be engaged with one-handed technology, and has a safety feature that allows the operator's hands to be placed behind exposed sharps even if the user must activate, Easy to use, function reliably and with a safety function that can be easily determined by the user whether the safety function is activated, cannot be stopped and remains protected during disposal It includes preferences for safety devices that are practical and safe and effective in caring for the patient.

  Each of these features is desirable, but some are not feasible in certain medical situations and are not applicable or available. For example, a needle is necessary whenever a skin penetration alternative is not available. Also, in some cases, a passive device may be preferred with a safety function that requires user activation. Devices must be considered individually by their true value and ultimately based on their ability to reduce workplace injury.

  Specifically, with respect to surgical scalpels, conventional surgical scalpels currently used in the medical industry include a metal grip and a disposable blade that is attached to the grip prior to use and removed after use. . The process of installing and removing the blade is a difficult and dangerous procedure that exposes the physician to the potential for injury from the exposed blade and contamination with blood that may be present on the blade. In addition, sharp surgeries may occur when the surgeon passes an exposed scalpel to a colleague during surgery.

  Current surgical safety scalpels are designed based on the concept of retracting a guard on a plastic grip or retracting a blade as if the entire scalpel is disposable. Since the scalpel is entirely disposable, it is not necessary to attach or remove the blade. The guard covers the blade before, during and after use, thus protecting the user from sharp injury.

  Surgeons accustomed to the feel that comes from the shape and weight of metal grips do not like current disposable surgical safety scalpels, especially because plastic grips are too light and "different" in feel. In use, the flexibility caused by the female plastic grip is less desirable than the female female knife. Furthermore, disposable surgical safety scalpels are much more expensive than typical disposable blades. These two factors currently limit the use of surgical safety scalpels in the medical industry.

  What is needed is a safe and reliable surgical scalpel that adequately protects medical personnel handling the scalpel while overcoming current objections to current designs from physicians. The present invention primarily relates to such devices.

  Briefly, the present invention in one preferred form comprises a female reusable metal grip that resembles a conventional metal grip that is preferred by most surgeons in shape and feel, and a blade before use. Conventional surgical scalpels are improved by providing a surgical safety scalpel that incorporates a disposable blade cartridge that is easy to install and remove from the scalpel metal grip during and after use.

  The surgical safety knife has a blade shape similar to a standard surgical blade, a blade holder that is permanently fixed to the blade, covers the blade, and the blade holder slides inwardly. A blade guard that can be adapted, a female grip for receiving a blade cartridge (the blade, blade holder and blade guard assembled together) and a lock. The knife grip is reusable, but the blade cartridge is disposable.

  Although the prior art design incorporates a disposable blade cartridge in which the blade guard slides off the releasably secured blade, the present invention slides the blade from the releasably secured guard. It is based on that.

  The present invention comprises a disposable safe blade cartridge that can be used with a female grip, preferably either reusable metal or disposable plastic. The blade cartridge is easy to fix to the female grip and is fixedly locked to the female grip. The blade is preferably movable through at least three distinct positions: an open position, a closed position and a locked position.

  Attachment and removal of the blade cartridge to and from the female grip is generally accomplished using a lateral approach perpendicular to the longitudinal axis of the female grip. When fastened to the knife grip, the movement of the blade guard is limited or does not move longitudinally, only the blade and blade holder of the blade cartridge can move longitudinally.

  In other embodiments, the blade cartridge itself is a stand-alone small scalpel fixedly attached to a metal passive grip, or the blade can move within a metal hollow grip.

  Reference will now be made in detail to the drawings. Throughout the drawings, like reference numerals designate like parts. The surgical safety scalpel 10 shown in FIG. 1 includes a scalpel grip 500 and a blade cartridge 400, and the blade cartridge 400 is fixedly attached to the scalpel grip 500 and safely detached from the scalpel grip 500. It is configured as follows. In the preferred embodiment of the present invention, the blade cartridge 400 is disposable, but the knife grip 500 is not disposable. Thus, a new blade cartridge 400 can be attached to the knife grip 500 for use by, for example, a physician. When the physician has finished using the surgical safety scalpel 10, the blade cartridge 400 can be safely removed from the scalpel grip 500 so that the blade cartridge 400 can be properly disposed of.

  To describe the relevance of the orientation of the various components of the surgical safety scalpel 10, the surgical safety scalpel 10 includes a longitudinal axis X that extends along the length of the surgical safety scalpel 10 and the surgical safety scalpel 10. It includes a vertical axis Z that is generally perpendicular to the longitudinal axis X along the width, and a horizontal axis Y along the height of the surgical safety knife 10. Thus, as used herein, longitudinal motion is referred to as motion along the longitudinal axis X, lateral motion is referred to as motion along the horizontal axis Y, and vertical motion is along the vertical axis Z. This is called the operation.

  The blade cartridge 400 includes a blade 100, a blade holder 200 adapted to be fixedly engaged with the blade 100, and a blade configured to slidably receive the blade 100 and the blade holder 200. A guard 300 may be provided. Furthermore, the blade holder 200 is adapted to move the blade 100 or a part thereof between a closed position and an open position. In the closed position, the blade 100 is safely and completely contained within the blade guard 300. In the open position, the blade 100 or a portion thereof extends outside the blade guard 300. According to the design, the blade 100 is in the closed position while not using the surgical safety knife 10 and in the open position while utilizing the surgical safety knife 10. Accordingly, the surgical safety knife 10 according to the present invention provides a safe and effective tool.

  As shown in FIGS. 2 and 3, the blade 100 includes a cutting edge 110 located at the distal end 105 of the blade 100. Further, the blade 100 defines an opening 120 at the proximal end 107. This is preferably an elongated opening 120 such as a slot. In addition to the illustrated shape of the cutting edge 110, the blade 100 has similar front and back surfaces.

  One skilled in the art will recognize that the blade 100 can be made of a variety of suitable materials including, but not limited to, carbon steel and stainless steel. In general, the carbon and stainless steels used to manufacture blade 100 are British Standard (“BS”) 2982: 1992, International Organization for Standardization (“ISO”) 7740: 1985 and European Standard (“EN”) 27740. Manufactured according to several industry standards including: 1992. The blade 100 may further be sterilized by gamma radiation, for example.

  As shown in FIG. 2, the blade holder 200 is designed to couple to the blade 100. Unlike the blade 100, the front and back of the blade holder 200 are not similar and the thickness of the blade holder 200 is non-uniform. The distal end of the blade holder 200 comprises a contoured holder projection 205 that extends vertically from the front surface of the blade holder 200 and generally coincides with the opening 120 of the blade 100. The holder protrusion 205 is adapted to be fixedly engaged with the opening 120 of the blade 100.

  The blade holder 200 may further include a protrusion notch 210 located proximal to the holder protrusion 205 that locks the blade 100 to the blade holder 200. As the holder protrusion 205 advances through the blade opening 120, the blade 100 snaps into the protrusion notch 210, thereby preventing the blade 100 from detaching from the blade holder 200.

  During assembly of the blade cartridge 400, the blade 100 is secured to the blade holder 200 by aligning the opening 120 of the blade 100 with the corresponding holder projection 205 of the blade holder 200. The holder protrusion 205 and protrusion notch 210 allow the blade 100 to slide over the blade holder 200 and plug into and snap into it, as shown in FIGS. Alternatively, the blade 100 may be articulated to the blade holder 200 by insert molding, and the blade holder 200 is formed around the blade 100 during the manufacturing process.

  The blade holder 200 further includes a holder knob 215 extending vertically from the front surface of the blade holder 200 at the proximal end. The surface of the holder knob 215 may include a ridge 220 for increasing traction when touching a finger during use of the surgical safety scalpel 10. As described in further detail below, the holder knob 215 is adapted to move the blade 100 between open and closed positions when in communication with the blade guard 300.

  As shown in FIGS. 4-6, the blade guard 300 is designed to slidably receive the blade 100 and the blade holder 200. When the blade 100 is in the closed position, the blade guard 300 fully surrounds the blade 100 so that the blade 100 does not inadvertently cut, stab, or otherwise damage material or individuals.

  The blade guard 300 includes an opening 315 (also referred to herein as a slot 315) for providing a path for the holder knob 215 of the blade holder 200 to slide between open / closed positions, see FIG. . Inevitably, as the holder knob 215 moves between the open / closed positions, the blade holder 200 and the blade 100 also move between the open / closed positions. More specifically, the directional force applied to the holder knob 215 of the blade holder 200 causes the holder knob 215 to slot when moving the blade 100 and the blade holder 200 between open / closed positions. Slid along 315.

  The blade guard 300 also includes at least one side rail 305 that defines a cavity within the blade guard 300. The blade 100 and blade holder 200 are preferably positioned between the two side rails 305, so that the blade 100 and blade holder 200 are within the cavity as the holder knob 215 slides within the slot 315. Slide. The holder knob 215 is positioned near the proximal end of the slot 315 when the blade 100 is in the closed position, and the holder knob 215 is positioned near the distal end of the slot 315 when the blade 100 is in the open position. It is done.

  As further shown in FIG. 7, the blade guard 300 includes a front catch 350 and a rear catch 355, which is positioned near the distal end of the slot 315, and the rear catch 355 is a proximal end of the slot 315. Is located near. The forward catch 350 is adapted to engage the holder knob 215 when the blade 100 is in the open position. The forward catch 350 prevents the blade holder 200 from moving the blade 100 forward beyond the open position. Similarly, the rear catch 355 is adapted to engage the holder knob 215 when the blade 100 is in the closed position. The rear catch 355 prevents the blade holder 200 from moving the blade 100 rearward beyond the closed position. Alternatively, the rear catch 355 prevents the blade holder 200 from moving the blade 100 rearward beyond a fully locked position.

  In order for the surgical safety scalpel 10 to be used effectively and stored safely, the blade 100 may be temporarily locked in the open / closed position. To facilitate temporary locking of the blade 100 in the closed position, the blade holder 200 further includes a stopper rib 225 positioned near the holder knob 215, see FIGS. In general, the stopper rib 225 extends laterally from the front surface of the blade holder 200.

  The stopper rib 225 is adapted to engage the rear retention slot 325 of the blade guard 300. The rear retention slot 325 is positioned near the proximal end of the blade guard 300 so that the stopper rib 225 engages the rear retention slot 325 when the blade 100 is in the closed position. While the stopper rib 225 and the rear holding slot 325 are engaged, the blade 100 is temporarily held in the closed position.

  To facilitate temporary locking of the blade 100 in the open position, the blade guard 300 further comprises a front retention slot 330 positioned near the distal end of the blade guard 300. When the blade 100 is in the open position, the stopper rib 225 of the blade holder 200 engages the front retaining slot 330. While the stopper rib 225 and the front holding slot 330 are engaged, the blade 100 is temporarily held in the open position.

  Alternatively, to further ensure that the blade 100 is properly locked in the open position during use of the surgical safety scalpel 10, the blade holder 200 includes a boss 230 that is generally positioned on top of the holder protrusion 205. But you can. As shown in FIGS. 9B and 13B, the boss 230 of the blade holder 200 is configured to engage the front slot 340 of the blade guard 300 (by an interference fit). The front slot 340 is positioned near the distal end of the blade guard 300 at the bottom surface of the blade guard 300. When the blade 100 is moved to the open position, the boss 230 of the blade holder 200 snaps into the front slot 340 of the blade guard 300 so that the blade 100 does not move laterally or vertically during use. To be prevented.

  In another alternative embodiment of the present invention, the blade 100 may be locked into a fully locked position before removing the blade cartridge 400 from the scalpel grip 500 or after the surgery is complete. As shown in FIGS. 15 and 16, the blade holder 200 includes at least one locking slot 235 positioned near the proximal end of the blade holder 200. The at least one locking slot 235 can snap into at least one locking rib 345 (positioned near the proximal end of the blade guard 300) of the blade guard 300 so that the blade 100 Is moved to the fully locked position. When the locking slot 235 engages the locking rib 345, the blade holder 200 is prevented from moving the blade 100 between the open / closed positions.

  Further, when the blade 100 is moved to the locked position, the blade 100 can no longer be released and extend to the forward open position for reuse. Typically, a backward force is applied to the holder knob 215 of the blade holder 200, thus moving the blade 100 beyond the closed position to the locked position.

  In certain preferred embodiments, the blade guard 300 further includes a plurality of tabs 365, see FIGS. 7, 9A and 13A, positioned in the front slot 340. FIG. As the holder projection 205 of the blade holder 200 slides into the front slot 340 as it is moved to the open position, the tabs 365 engage the holder projection 205 (by an interference fit) so that the blade 100 can be moved laterally or It is prevented from moving in the vertical direction.

  Those skilled in the art will recognize that the blade holder 200 and blade guard 300 may be made of a variety of materials including, but not limited to, plastics such as acrylonitrile-butadiene-styrene (ABS) copolymer plastic. Will be done.

  As described above, the blade 100 and the blade holder 200 fit within the blade guard 300. These three elements together form a blade cartridge 400. The blade cartridge 400 can be attached / removed from the distal end of the female grip 500.

  The distal end 505 of the scalpel grip 500 is cut at the front surface 510 to accommodate the blade cartridge 400. The female grip 500 includes at least one lateral extension 540, a lower wall 560, a lower protrusion 550, and alternatively at least one inner notch 530, as shown in FIGS. 8A-8C. (See FIG. 9B). Preferably, there are two lateral extensions 540 near the distal end 505 of the female grip 500, with the first lateral extension 540 in the opposite direction to the second lateral extension 540. It is positioned so as to extend. Accordingly, the first lateral extension 540, the second lateral extension 540, and the female grip 500 generally form a T shape. The lateral extension 540 is adapted to engage the distal end of the blade cartridge 400 when the blade cartridge 400 is attached to the knife grip 500.

  The lower wall 560 communicates with the proximal end of the blade cartridge 400 when the blade cartridge 400 is attached to the female grip 500 as shown in FIG. 9A. In general, the distance between the lateral extension 540 of the knife grip 500 and the lower wall 560 is approximately equal to the length of the blade cartridge 400. Both the lateral extension 540 and the lower wall 560 prevent the blade cartridge 400 from moving in the longitudinal direction when attached to the knife grip 500.

  The lower protrusion 550 is positioned on the front surface 510 of the female grip 500 and extends from the lower wall 560 in the longitudinal direction. Typically, the blade cartridge 400 rests on the lower protrusion 550 while attached to the knife grip 500.

  Alternatively, as shown in FIGS. 9B and 14, the at least one inner notch 530 is adapted to engage at least one catch 335 of the blade cartridge 400 (eg, the catch 335 of the blade guard 300). . When the blade cartridge 400 is attached to the knife grip 500, the catch 335 of the blade cartridge 400 snaps into the notch 530, preventing the blade cartridge 400 from moving in the longitudinal direction.

  In another embodiment, the side edge of the blade guard 300 includes a beveled end at the proximal end of the blade cartridge 400. The angled end of the blade guard 300 engages the lower wall 560 of the scalpel grip 500 and is adapted to prevent longitudinal movement of the blade cartridge 400 during use of the surgical safety scalpel 10. The

  In order to correctly attach the blade cartridge 400 to the female grip 500, the female grip 500 further comprises at least one support rib 535. Preferably, two support ribs 535 are positioned on each side of the distal end 505 of the female grip 500. The blade cartridge 400 includes at least one rail 305 that is adapted to engage the support rib 535 of the female grip 500. Engagement of rail 305 and support rib 535 temporarily holds attachment of blade cartridge 400 to distal end 505 of female grip 500.

  As shown in FIG. 8A, the scalpel grip 500 further includes a tapered portion 545 positioned near the lateral extension 540. The tapered portion 545 of the female grip 500 assists in the attachment and removal of the blade cartridge 400 from the female grip 500. Inevitably, the taper portion 545 of the female grip 500 slightly tapers the support rib 535 of the female grip 500. Since the female grip 500 includes a tapered portion 545, a portion of the side rail 305 of the blade cartridge 400 only overcomes the support rib 535 of the female grip 500 while being attached to and detached from the female grip 500. Good.

  During use of the surgical safety scalpel 10, the scalpel grip 500 includes a plurality of grooves 525 positioned on the back surface 515 of the scalpel grip 500 to improve the traction force of the scalpel grip 500 when touching a finger. As shown in FIG. 8, the plurality of grooves 525 are positioned at the distal end 505 of the scalpel grip 500, thus preventing the plurality of grooves 525 from slipping the surgical safety scalpel 10 during use.

  As shown in FIGS. 1, 9 and 10, the scalpel grip 500 may include a display 555. The display 555 is generally positioned on the front surface 510 near the proximal end 507 of the female grip 500. One skilled in the art will recognize that the display 555 of the present invention may include multiple markings or prints, but the display 555 is preferably metric, yard-pound, or any other suitable A measurement unit such as, but not limited to, a measurement system.

  The knife grip 500 is designed to receive the blade cartridge 400 and give the user a conventional knife feel in use. This is therefore provided in materials, weight and design for comfortable use by the user.

Cartridge Assembly The blade cartridge 400 includes a mating engagement of the blade 100, blade holder 200, and blade guard 300, as shown in FIG. Preferably, the blade cartridge 400 is assembled at a location other than where the surgical safety scalpel 10 is ultimately used, e.g., at the factory, so that only the assembled blade cartridge 400 is delivered to the user. . Further, as described above, the blade 100 may be attached to the blade holder 200 by insert molding, and the blade holder 200 is actually manufactured and molded around the blade 100. When using insert molding, the blade 100 does not need to be subsequently attached to the blade holder 200.

  The blade cartridge 400 may be delivered in a unique disinfected wrapping state, such as a foil wrap. Accordingly, the blade cartridge 400 is not assembled by the user, but merely fits the blade cartridge 400 into the female grip 500.

  As previously mentioned, the blade 100 is secured to the blade holder 200 by aligning the position of the blade opening 120 with the corresponding holder projection 205 of the blade holder 200. The protruding notch 210 allows the blade 100 to slide over the blade holder 200 and be inserted into the blade holder 200 and snap into place, as shown in FIGS.

  The blade holder 200 is then attached to the blade guard 300 along with the blade 100 by sliding and inserting the blade holder 200 on the side rails 305 of the blade guard 300. The side rails 305 of the blade guard 300 do not extend over the entire length of the blade guard 300, so that the cavity within the blade guard 300 is wider near the proximal end of the blade guard 300. . Such a wider cavity aids the insertion of the blade 100 and blade holder 200 into the blade guard 300. To mount blade 100 and blade holder 200 into blade guard 300, blade 100 and blade holder 200 are pushed into blade guard 300, and blade 100 is a cavity defined by the sides of blade guard 300. And the holder knob 215 fits into the slot 315. As shown in FIGS. 4-6, the blade holder 200 is inserted over the blade guard 300 such that the stopper rib 225 on the blade holder 200 engages the rear retention slot 325 of the blade guard 300. It is.

  The blade holder 200 and blade 100 were temporarily locked to the blade guard 300 by the holder's stopper ribs 225 engaging and locking the corresponding rear retention slots 325 on the blade guard 300. To be left. Accordingly, the blade 100 may be held in the closed position.

  In the assembled blade cartridge 400, the blade 100 is completely enclosed within the blade guard 300 until attached to the knife grip 500 for use. As shown in FIG. 11, to remove the blade 100 from the closed position, the user must depress the holder knob 215 and then push the holder knob 215 forward. Therefore, accidental removal of the blade 100 is prevented.

Cartridge Installation In order to attach the blade cartridge 400 to the knife grip 500, the blade cartridge 400 must approach the knife grip 500 in a direction generally perpendicular to the longitudinal axis X of the knife grip 500. In general, the blade cartridge 400 is attached to the scalpel grip 500 between the lateral extension 540 and the lower wall 560.

  While holding the blade cartridge 400 with one hand, the user connects the first inner end of the blade cartridge 400 (eg, the first rail 305 of the blade cartridge 400) to the first outer end ( For example, it is positioned on the first support rib 535). The user then moves the blade cartridge 400 such that the second inner end of the blade cartridge 400 (eg, the second rail 305 of the blade cartridge 400) is the second outer end of the female grip 500 (eg, the first The second support rib 535) in a direction generally perpendicular to the longitudinal axis X of the female grip 500. The second inner end 305 of the blade cartridge 400 snaps into and engages the second support rib 535 of the female grip 500.

  Alternatively, the catch 335 of the blade cartridge 400 snaps into the inner notch 530 of the female grip 500 and engages it. Accordingly, the blade cartridge 400 is securely fixed to the female grip 500.

  As shown in FIGS. 9A to 9B, the longitudinal movement of the blade guard 300 is limited and preferably prevented by the lateral extension 540 and the lower wall 560 of the scalpel grip 500.

  Further, as shown in FIGS. 7 and 10, the blade cartridge 400 (eg, blade guard 300) includes at least one groove 360 positioned near one side of the blade cartridge 400. Preferably, each two grooves 360 located on opposite sides of the blade cartridge 400 increase the flexibility of the blade cartridge 400 during removal from the scalpel grip 500. The groove 360 of the blade cartridge 400 causes the side of the blade cartridge 400 to bend upward while the blade cartridge 400 is removed from the knife grip 500.

Surgical Scalpel Use When initially assembled, the blade 100 in the blade cartridge 400 is in the closed position as shown in FIG. The blade 100 depresses the holder knob 215 of the blade holder 200 (e.g., pushes the holder knob 215 down) and moves the stopper rib 225 on the blade holder 200 from the rear retaining slot 325 on the blade guard 300. Remove the holder knob 215 along the slot 315 of the blade guard 300 so that the blade 100 reaches the open position and the stopper rib 225 on the blade holder 200 engages the front retaining slot 330 on the blade guard 300 Is extended from the blade guard 300 by sliding until released. Accordingly, the blade 100 is temporarily locked in the open position.

  When in the open position, the blade 100 and blade holder 200 are secured in the slot 340 by an interference fit between the tab 365 and the holder projection 205 as shown in FIGS. 7 and 9A. In this open position, the surgical safety knife 10 is ready for use. The interference fit between the tab 365 and the holder projection 205 prevents the blade 100 from moving laterally and vertically during use of the surgical safety knife 10.

  Alternatively, blade 100 and blade holder 200 are further secured to blade guard 300 by an interference fit between boss 230 on blade holder 200 and front slot 340 on blade guard 300 as shown in FIGS. 9B and 13B. Is done. The interference fit between the boss 230 and the front slot 340 prevents the blade 100 from moving laterally and vertically during use of the surgical safety knife 10.

  Blade cartridge 400 (eg, blade guard 300) further includes a plurality of jagged edges 310, as shown in FIGS. The plurality of jagged edges 310 are positioned on at least one side of the blade guard 300, and thus the plurality of jagged edges 310 increase the grip of the surgical safety knife 10 during use.

  If the surgeon needs to hand the surgical safety knife 10 to a colleague, the surgeon first depresses the holder knob 215 on the blade holder 200 to disengage the stopper rib 225 from the front retaining slot 330 and the holder knob 215. Along the slot 315 of the blade guard 300, the blade 100 reaches the closed position and the stopper rib 225 on the blade holder 200 is released to re-engage with the rear retaining slot 325 on the blade guard 300. The blade 100 is moved to the closed position by sliding backward. The blade 100 is temporarily locked in the closed position at this point. The blade 100 may be moved any number of times between the open / closed positions until the surgery is complete.

Cartridge Removal In order to remove the blade cartridge 400 from the knife grip 500, the blade cartridge 400 must be removed from the knife grip 500 in a direction generally perpendicular to the longitudinal axis X of the knife grip 500. Therefore, the user cannot push the blade cartridge 400 away from the knife grip 500 in the longitudinal direction due to the laterally extending portion 540. If it is possible to remove the blade cartridge 400 longitudinally from the scalpel grip 500, the blade cartridge 400 may be in the direction of the incision previously created by the surgical safety scalpel 10, or in another undesirable direction or May be accidentally pushed or pushed to a location. The present invention eliminates this possibility.

  Removal of the blade cartridge 400 occurs after the blade 100 has been moved to a closed or fully locked position. In order to remove the blade cartridge 400 from the female grip 500, the user can connect one end of the blade cartridge 400 (eg, the first rail 205 of the blade cartridge 400 to the corresponding outer end of the female grip 500). For example, the support rib 535 is slightly removed from the support rib 535. The user then rotates the blade cartridge 400 in a direction generally perpendicular to the longitudinal axis X of the female grip 500. Such rotation causes the first of the blade cartridge 400 to rotate. One end (eg, the first rail 205 of the blade cartridge 400) is completely disengaged from the outer end (eg, the first support rib 535) of the female grip 500. Next, the blade cartridge 400 is safe. Discarded.

  In certain alternative embodiments, the blade cartridge 400 further provides at least one ridge 370 positioned on at least one side of the blade guard 300, as shown in FIGS. 4, 8B and 8C. The at least one ridge 370 of the blade cartridge 400 increases traction and support during removal of the blade cartridge 400 from the female grip 500. A user can place a finger on the at least one ridge 370 to assist in separating the first end of the blade cartridge 400 and the first outer end of the female grip 500.

  Further, as shown in FIGS. 7 and 10, the two grooves 360 located on opposite sides of the blade cartridge 400 increase the flexibility of the blade cartridge 400 during removal from the scalpel grip 500. The groove 360 of the blade cartridge 400 allows the side of the blade cartridge 400 to deflect upward while removing the blade cartridge 400 from the knife grip 500.

Disposable Surgical Safety Scalpel In yet another alternative embodiment of the present invention, the surgical safety scalpel 10 includes a disposable scalpel grip 500 so that the disposable scalpel grip 500 is separated from the blade cartridge 400. It is passive. The disposable knife grip 500 is adapted to attach to the blade cartridge 400. Preferably, the blade cartridge 400 and the disposable scalpel grip 500 are permanently secured to each other during the manufacturing process of the surgical safety scalpel 10 in the factory. After use, the blade cartridge 400 and the disposable female grip 500 are properly discarded.

  One skilled in the art will recognize that the disposable female grip 500 may be made of a variety of materials including, but not limited to, plastics such as acrylonitrile-butadiene-styrene (ABS) copolymer plastic. I will.

  In yet another alternative embodiment of the present invention, the surgical safety scalpel 10 includes a disposable scalpel grip 500 having a slidable blade 100 and a blade holder 200 received therein. Accordingly, the blade guard 300 is an integral part of the disposable female grip 500 and therefore cannot be detached from the female grip 500. Further, the entire surgical safety knife 10 can be discarded after use.

  The blade 100 and the blade holder 200 may be attached by aligning the position of the opening 120 of the blade 100 with the holder protrusion 205 of the blade holder 200 as described above. Alternatively, the blade 100 and the blade holder 200 may be attached via insert molding, so that the blade holder 200 is formed around the blade 100 during the manufacturing process.

  The blade holder 200 further comprises a holder knob 215 extending vertically from the front surface of the blade holder 200 at the proximal end. The surface of the holder knob 215 may include a ridge 220 for increasing traction when touching a finger during use of the surgical safety scalpel 10.

  The blade guard 300 is integral with the disposable knife grip 500 and defines a cavity that slidably receives the blade 100 and the blade holder 200. When in the closed position, the blade holder 200 completely surrounds the blade 100, but when in the open position, a portion of the blade 100 extends out of the blade guard 300.

  The blade guard 300 further includes an opening 315 (or slot 315) that provides a trajectory for the holder knob 215 that slides between open / closed positions. As previously mentioned, when the blade 100 is in the closed position, the holder knob 215 is positioned near the proximal end of the slot 315, and when the blade 100 is in the open position, the holder knob 215 is in the slot 315. Located near the distal end.

  The blade guard 300 includes a front catch 350 and a rear catch 355 that is positioned near the distal end of the slot 315 and the rear catch 355 is positioned near the proximal end of the slot 315. The forward catch 350 is adapted to engage the holder knob 215 when the blade 100 is in the open position. The forward catch 350 prevents the blade holder 200 from moving the blade 100 forward beyond the open position. Similarly, the rear catch 355 is adapted to engage the holder knob 215 when the blade 100 is in the closed position. The rear catch 355 prevents the blade holder 200 from moving the blade 100 rearward beyond the closed position. Alternatively, the rear catch 355 prevents the blade holder 200 from moving the blade 100 rearward beyond a fully locked position.

  The blade 100 may be temporarily locked in the open / closed position so that the surgical safety scalpel 10 can be used effectively and stored safely. To facilitate temporary locking of the blade 100 in the closed position, the blade holder 200 further includes a stopper rib 225 positioned near the holder knob 215, see FIGS. In general, the stopper rib 225 extends laterally from the front surface of the blade holder 200.

  The stopper rib 225 is adapted to engage the rear retention slot 325 of the blade guard 300. The rear retention slot 325 is positioned near the proximal end of the blade guard 300 and the stopper rib 225 engages the rear retention slot 325 when the blade 100 is in the closed position. While the stopper rib 225 and the rear holding slot 325 are engaged, the blade 100 is temporarily held in the closed position.

  To facilitate temporary locking of the blade 100 in the open position, the blade guard 300 further comprises a front retention slot 330 positioned near the distal end of the blade guard 300. When the blade 100 is in the open position, the stopper rib 225 of the blade holder 200 engages the front retaining slot 330. While the stopper rib 225 and the front holding slot 330 are engaged, the blade 100 is temporarily held in the open position.

  Alternatively, to further ensure that the blade 100 is properly locked in the open position during use of the surgical safety scalpel 10, the blade holder 200 includes a boss 230 that is generally positioned on top of the holder protrusion 205. But you can. As shown in FIGS. 9B and 13B, the boss 230 of the blade holder 200 is configured to engage the front slot 340 of the blade guard 300 (by an interference fit). The front slot 340 is positioned near the distal end of the blade guard 300 at the bottom surface of the blade guard 300. When the blade 100 is moved to the open position, the boss 230 of the blade holder 200 snaps into the front slot 340 of the blade guard 300, preventing the blade 100 from moving laterally or vertically during use. .

  Alternatively, after completion of the surgical procedure, the blade 100 may be locked into a fully locked position before the surgical safety knife 10 is discarded. As shown in FIGS. 15 and 16, the blade holder 200 includes at least one locking slot 235 positioned near the proximal end of the blade holder 200. The locking slot 235 snaps into at least one locking rib 345 (positioned near the proximal end of the blade guard 300) of the blade guard 300, which moves the blade 100 to a fully locked position. Is done. When the locking slot 235 engages the locking rib 345, the blade holder 200 is prevented from moving the blade 100 between the open / closed positions.

  Further, when the blade 100 is moved to its locked position, the blade 100 can no longer be released for reuse and extend to the forward open position. Typically, a reverse force is applied to the holder knob 215 of the blade holder 200, causing the blade 100 to move beyond the closed position to the locked position.

  The blade guard 300 further includes a plurality of tabs 365 positioned in the front slot 340. When the holder projection 205 of the blade holder 200 is moved to the open position and slides within the front slot 340, the tabs 365 engage the holder projection 205 (by an interference fit) and the blade 100 moves laterally or vertically. To be prevented.

  To increase the traction force of the scalpel grip 500 when a finger comes into contact during use of the surgical safety scalpel 10, the scalpel grip 500 includes a plurality of grooves 525 that are positioned on the back surface 515 of the scalpel grip 500. As shown in FIGS. 8A-8C, a plurality of grooves 525 are positioned at the distal end 505 of the scalpel grip 500, and the plurality of grooves 525 prevent the surgical safety scalpel 10 from slipping during use.

  As shown in FIGS. 1, 9A and 10, the female grip 500 may include an indicator 555. The display 555 is generally positioned on the front surface 510 near the proximal end 507 of the female grip 500. One skilled in the art will recognize that the display 555 of the present invention may include multiple markings or prints, but the display 555 is preferably metric, yard-pound, or any other suitable A measurement unit such as, but not limited to, a measurement system.

  The blade 100 depresses the holder knob 215 of the blade holder 200 (e.g., pushes the holder knob 215 down) and moves the stopper rib 225 on the blade holder 200 from the rear retaining slot 325 on the blade guard 300. Remove the holder knob 215 along the slot 315 of the blade guard 300 so that the blade 100 reaches the open position and the stopper rib 225 on the blade holder 200 engages the front retaining slot 330 on the blade guard 300 Is extended from the blade guard 300 by sliding until released. Accordingly, the blade 100 is temporarily locked in the open position.

  When in the open position, the blade 100 and blade holder 200 are secured in the slot 340 by an interference fit between the tab 365 and the holder projection 205 as shown in FIGS. 7, 9A and 13A. In this open position, the surgical safety knife 10 is ready for use. The interference fit between the tab 365 and the holder projection 205 prevents the blade 100 from moving laterally and vertically during use of the surgical safety knife 10.

  Alternatively, blade 100 and blade holder 200 are further secured to blade guard 300 by an interference fit between boss 230 on blade holder 200 and front slot 340 on blade guard 300 as shown in FIGS. 9B and 13B. Is done. The interference fit between the boss 230 and the front slot 340 prevents the blade 100 from moving laterally and vertically during use of the surgical safety knife 10.

  The blade guard 300 further includes a plurality of jagged edges 310, as shown in FIGS. The plurality of jagged edges 310 are positioned on at least one side of the blade guard 300, and thus the plurality of jagged edges 310 increase the grip of the surgical safety knife 10 during use.

  If the surgeon needs to hand the surgical safety knife 10 to a colleague, the surgeon first depresses the holder knob 215 on the blade holder 200 to disengage the stopper rib 225 from the front retaining slot 330 and the holder knob 215. Along the slot 315 of the blade guard 300, the blade 100 reaches the closed position and the stopper rib 225 on the blade holder 200 is released to re-engage with the rear retaining slot 325 on the blade guard 300. The blade 100 is moved to the closed position by sliding backward. The blade 100 is temporarily locked in the closed position at this point. The blade 100 may be moved any number of times between the open / closed positions until the surgery is complete.

  Further, the blade guard 300 may include a plurality of knob tabs that are adapted to engage the holder knob 215 of the blade holder 200 when in the open / closed position. The interference fit between the holder knob 215 and the knob tab prevents longitudinal movement of the holder knob 215 during use of the surgical safety knife 10.

  The blade guard 300 may further include a plurality of retention slot tabs positioned within the front retention slot 330 that engage the stopper ribs 225 when the blade 100 is in the open position. Adapted to do. The interference fit between the retention slot tab and the stopper rib 225 prevents longitudinal movement of the blade 100 during use of the surgical safety knife 10.

  Those skilled in the art will appreciate that scalpel grip 500 (eg, surgical safety scalpel 10 minus blade 100) includes, but is not limited to, plastics such as acrylonitrile-butadiene-styrene (ABS) copolymer plastic. It will be appreciated that other materials may be manufactured.

  Although the present invention has been disclosed in its preferred form, those skilled in the art will recognize that the present invention does not depart from the spirit and scope of the present invention as set forth in the appended claims and equivalents thereof. It will be apparent that modifications, additions and deletions can be made.

FIG. 5 is a perspective view of a blade cartridge and a passive female grip according to a preferred embodiment of the present invention. FIG. 3 is a perspective view of the blade and blade holder with the blade removed from the blade holder, in accordance with a preferred embodiment of the present invention. FIG. 3 is a perspective view of the blade and blade holder with the blade fixedly attached to the blade holder, in accordance with a preferred embodiment of the present invention. FIG. 3 is a perspective view showing a blade guard for engaging a blade and a blade holder according to a preferred embodiment of the present invention. FIG. 3 is a bottom view of a blade guard that engages the blade and blade holder such that the blade holder is slidably received within the blade guard, in accordance with a preferred embodiment of the present invention. FIG. 6 is a bottom view of a blade guard that engages a blade and blade holder such that a portion of the blade holder is received in a rear retention slot, in accordance with a preferred embodiment of the present invention. FIG. 3 is a perspective view of a blade guard engaging a blade and blade holder, showing the blade holder in a closed position, according to a preferred embodiment of the present invention. 8A-8C are bottom views showing a blade cartridge received at the distal end of a female grip, generally referred to as FIG. 8, according to a preferred embodiment of the present invention. FIGS. 9A-9B illustrate blade blades received at the distal end of the female grip such that the support ribs of the female grip secure the blade cartridge onto the female grip, according to a preferred embodiment of the present invention. It is a perspective view which shows a cartridge, and is generally called FIG. FIG. 6 illustrates a blade cartridge received by the distal end of a scalpel grip so that the blade is completely enclosed by the blade guard when the blade holder is in the closed position, according to a preferred embodiment of the present invention. It is a top view. In accordance with a preferred embodiment of the present invention, the blade cartridge is received at the distal end of the female grip, including a slot that allows sliding between the closed and open positions by the holder knob. It is a perspective view which shows a cartridge. FIG. 6 is a perspective view of a blade cartridge being received at the distal end of a scalpel grip such that the blade and blade holder are in an open position, in accordance with a preferred embodiment of the present invention. 13A-13B are perspective views showing the blade and blade holder of the blade cartridge in an open position so that the blade does not move laterally and transversely according to a preferred embodiment of the present invention, generally as shown in FIG. Call. FIG. 13B shows an alternative embodiment in which the blade holder boss engages the blade guard so that the blade does not move laterally and transversely. FIG. 6 is a perspective view of a blade cartridge engaging a distal end of a female grip, according to an alternative embodiment of the present invention. FIG. 6 is a perspective view showing a blade and blade holder in a closed position, according to an alternative embodiment of the present invention. FIG. 7 is a perspective view showing a blade and blade holder in a fully locked position, according to an alternative embodiment of the present invention.

Claims (15)

A surgical safety knife,
A disposable blade cartridge;
A non-disposable female grip having a distal end,
The user positions the disposable blade cartridge on the distal end of the non-disposable female grip and the first inner end of the blade cartridge over the first outer end of the female grip, by turning around an axis substantially parallel to the longitudinal axis of the scalpel handle such that the second inner end snap fitted into a second outer end of the scalpel handle, as attached, that is configured Surgical safety knife. The disposable blade cartridge is
The blade,
A blade holder communicating with the blade;
And a blade guard which is adapted to receive the blade and the blade holder, surgical safety scalpel of claim 1.   The blade defines an opening near the proximal end of the blade, and the blade holder includes a protrusion positioned near the distal end of the blade holder so that the protrusion of the blade holder is The surgical instrument of claim 2, adapted to engage an opening, wherein the projection of the blade holder comprises a notch adapted to securely lock the blade onto the blade holder. Safety knife.   The surgical safety knife according to claim 2, wherein the blade is attached to the blade holder via insert molding such that the blade holder is formed around the blade.   The surgical device of claim 3, wherein the blade holder is adapted to move a portion of the blade between a closed position inside the blade guard and an open position outside the blade guard. Safety knife for use.   The surgical instrument of claim 5, wherein the blade holder further comprises a holder knob positioned near a proximal end of the blade holder, the holder knob being movable along a slot in the blade guard. Safety knife for use.   The blade guard is adapted to engage the holder knob at the distal end of the slot and to engage the holder knob at the proximal end of the slot. And the rear catch prevents the blade holder from moving the blade forward beyond the open position, and the rear catch includes the blade holder The surgical safety knife according to claim 6, wherein the surgical safety knife is prevented from moving backward beyond the closed position or the locked position. The blade holder is adapted to engage the rear holding slot of the guard when the blade is in the closed position and is inserted into the front holding slot of the guard when the blade is in the open position. Further comprising stopper ribs adapted to engage;
Engagement of the stopper rib and the rear retaining slot, the blade is temporarily held in the closed position, engagement, the open position of the blade with the stopper rib and the front retaining slot The surgical scalpel according to claim 6, wherein the surgical safety knife is temporarily held in the surgical knife.   The slot of the blade guard includes a plurality of tabs adapted to engage the protrusion when the blade is in the open position, the engagement between the tab and the protrusion being in use. The surgical safety knife according to claim 8, which prevents movement of the blade in a lateral and vertical direction.   The blade holder further comprises at least one locking slot adapted to engage at least one locking rib of the guard when the blade is in the locked position, the blade holder comprising the blade holder The surgical safety knife of claim 8, wherein the blade prevents the blade from moving. The non-disposable female grip is
At least one lateral extension adapted to engage the distal end of the disposable blade cartridge;
A lower wall adapted to engage the proximal end of the disposable blade cartridge,
The surgical safety knife of claim 2 wherein the at least one lateral extension and lower wall prevent longitudinal movement of the disposable blade cartridge when attached to the non-disposable knife grip.   The non-disposable female grip further comprises at least one support rib adapted to engage at least one rail of the disposable blade cartridge, the at least one support rib and the at least one 12. The surgical safety knife of claim 11 wherein engagement with one rail temporarily retains the mounting of the disposable blade cartridge on the non-disposable knife grip.   The disposable blade cartridge further comprises at least one groove positioned near at least one side of the disposable blade cartridge, the at least one groove being removable from the non-disposable female grip. The surgical safety knife of claim 2, wherein the surgical blade scalpel increases the flexibility of the disposable blade cartridge.   The blade cartridge further comprises at least one laterally extending catch positioned near a proximal end of the blade guard, so that the at least one laterally extending catch comprises: When the blade cartridge is attached to the blade grip, it engages at least one inner notch located on at least one side of the blade grip, and the at least one laterally extending catch and the at least one The surgical safety knife according to claim 2, wherein engagement with one inner notch prevents longitudinal movement of the blade cartridge.   The blade guard further comprises at least one ridge positioned on at least one side of the blade guard, the at least one ridge having a traction force while the blade cartridge is removed from the female grip. The surgical safety scalpel according to claim 2, which increases support.

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